Integrative Care for Type 2 Diabetes

The Canadian College of Naturopathic Medicine

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Other: Usual (Conventional) Care; Other: Naturopathic Care

Study type: Interventional

Funder types: Other

Identifiers

NCT02843724

CanadianCNN

Details and patient eligibility

About

A two year, two arm pragmatic trial to investigate the integration of naturopathic care with conventional medical care to provide additional benefit beyond that of conventional medical care alone in achieving adequate control of diabetes.

Enrollment: 148 estimated patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males or females, enrolled as a patient with WE-FHT
• Ages 21-75 years old
• Diagnosed with type 2 diabetes and not adequately controlled (HbA1c > 7.0mmol/L)
• Currently seeking care with a medical doctor, nurse practitioner and/or physician assistant
• Willingness to adhere to randomized treatment with availability for follow-up
• Ability to answer self- and interviewer- administered questions in English or have an English speaking caregiver who can aid in answering self- and interviewer- administered questions
• Ability to provide written informed consent or give informed consent through substitute decision maker
• Capacity to maintain a diary and log of treatments and recommendations given during study

Exclusion criteria

• Lacking capacity for consent

• Pregnancy or an intention to become pregnant in the following two years

• Breastfeeding

• History of myocardial infarction within the past 6 months

• Chronic kidney (eGFR <30 mL/min) or liver disease

• Actively receiving care from a complex care diabetes clinic

• History of severe hypoglycemia in the last year resulting in hospital emergency care [where hypoglycemia is defined to be: 1) development of autonomic or neuroglycopenic symptoms, 2) low plasma glucose level (<4.0mmol/L for patients treated with insulin or an insulin secretagogue) and 3) symptoms responding to the administration of carbohydrate] or hypoglycemia unawareness

• Current bolus or pre-mixed insulin treatment

• Limited life expectancy (< 6 months)

• High level of functional dependency (inability to perform common activities of daily living)

• In participants aged 65yoa to 75yoa, the following also serve as exclusion criteria:

  1. Recent MI or stroke (within last 6 months)
  2. NYHA CHF Functional Capacity Stage III or above
  3. NYHA CHF Objective Assessment Stage C or greater (http://www.heart.org/HEARTORG/Conditions/HeartFailure/AboutHeartFailure/Classes-of-Heart-Failure_UCM_306328_Article.jsp)
  4. Planned revascularization procedure (PCI or coronary artery bypass graft) or coronary angiogram within 90 days after screening or randomization

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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148 participants in 2 patient groups

Control (Conventional) Arm

Active Comparator group

Description:

Treatment of Type 2 Diabetes according to the Canadian Diabetes Association guidelines. Participants' other health concerns to be addressed as per usual care by practitioners at Wise-Elephant Family Health Team.

Treatment:

Other: Usual (Conventional) Care

Integrative (Naturopathic + Conventional) Arm

Active Comparator group

Description:

In addition to conventional care, participants will receive free naturopathic care at Brampton Naturopathic Teaching Clinic (located within the Brampton Civic Hospital). Senior student clinicians will provide care under the direct supervision of licensed naturopathic doctors. A naturopathic menu of treatment options have been designed to reflect naturopathic practice and vetted by 3 licensed naturopathic doctors and experts in the field. Participants' other health concerns will be addressed as per naturopathic doctors' discretion.

Treatment:

Other: Naturopathic Care

Other: Usual (Conventional) Care